Category:
VIGILANCE GUIDANCE DOCUMENTS
This document is part of the joint action ‘785269/GAPP’, which has received funding from the European Union’s Health Programme (2014-2020).
The main scope of the guideline is to define how a PPA programme should or could be organised. This document provides recommendations to Competent Authorities to have a common approach for a Preparation Process Authorisation (PPA). For that, different steps are described throughout the guideline to assess the PPA.